Status:
COMPLETED
Phase I/II Study of Chemoprevention With EGFR and COX-2 Inhibitor
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Precancerous Conditions
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluate effect on cells and patient response to study medications, assess side effects of these medications, and evaluate chemicals in cells that may tell how the drug works, before, and after receiv...
Detailed Description
The purpose of this study is to evaluate the effect on cells and patient response to study medications, assess the side effects of these medications, and to evaluate chemicals in the cells that may te...
Eligibility Criteria
Inclusion
- Participants must have premalignant lesions.
- Lesion sites include oral cavity, oropharynx, and larynx.
- Must have at least a \>20 pack-year history of smoking.
- Must have a Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-1.
- Participants must be 18 years of age or older.
- No contraindications for laryngoscopy and biopsy.
- Adequate liver function.
- Must have hemoglobin and hematocrit levels at or above the lower limit of the normal range.
- Participants must have prothrombin time (PT)/partial thromboplastin time (PTT) levels at or above the lower limit of the normal range.
- Women of child-bearing potential must have a negative serum pregnancy test within 72 hours of receiving treatment.
- Must be able to swallow the oral dose of erlotinib and celecoxib.
- Participants must be disease free.
- Final eligibility will be determined by the health professionals conducting the trial.
Exclusion
- Participants with acute intercurrent illness or those who had surgery within the preceding 4 weeks unless they have fully recovered.
- History of previous malignancies unless the cancer was stage I or II and rendered free of disease more than 1 year.
- Pregnant or breast feeding.
- Not practicing adequate contraception if the participants are of child bearing potential.
- Female patients who have a positive pregnancy test.
- History or recent myocardial infarction.
- Hypertension not adequately controlled by medication.
- Documented history of coagulopathy.
- Documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) Grade II.
- Participants who were taking COX-2 inhibitors or EGFR tyrosine kinase inhibitors within 3 months of study entry.
- Documented history or interstitial lung disease.
- Known connective tissue disease.
- History of nonsteroidal antiinflammatory drug (NSAID)-induced ulcers or those who are at risk for a GI ulcer.
- Participated in a clinical trial of an investigational drug within 12 months prior to enrollment.
- Final eligibility will be determined by the health professionals conducting the trial.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00314262
Start Date
October 1 2006
End Date
November 1 2012
Last Update
October 24 2014
Active Locations (1)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322